Japanese Phase 1 Multiple Ascending Dose (MAD) Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Placebo matching BMS-820836; Drug: BMS-820836

Study type: Interventional

Funder types: Industry

Identifiers

NCT01396252

CN162-014

Details and patient eligibility

About

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.

Enrollment: 57 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese subjects and Japanese patients with depression (Hamilton Rating Scale for Depression (HAM-D) ≥ 14), ages 20 to 55 years.

Exclusion criteria

• Any significant acute or chronic medical illness.
• Non-compliance, or overall not suitable as determined by the investigator.
• History of, or current clinically significant psychiatric disorders or illnesses, substance abuse or dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Arm1: BMS-820836

Experimental group

Description:

Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Arm 2: Placebo matching BMS-820836

Placebo Comparator group

Description:

Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg)

Treatment:

Drug: Placebo matching BMS-820836